On Tuesday, India’s largest drug maker Sun Pharma announced that the US Food and Drug Administration (FDA) had approved its biologic drug branded Ilumya (tildrakizumab) for the treatment of moderate to severe plaque psoriasis. The drug is delivered subcutaneously through an injection.
The background
In September 2014, Sun Pharma had obtained the licence for the drug from Merck of US, for USD 80 million (Rs 505 crore). The drug was in phase III trials at the time of the deal.
Merck was to continue with the clinical development and regulatory activities with funding from Sun Pharma. Upon product approval, Sun Pharma had agreed to be responsible for regulatory activities, post-approval studies, manufacturing and commercialisation. Merck is eligible to receive undisclosed payments associated with regulatory (including product approval) and sales milestones, as well as tiered royalties.
Last year Sun Pharma signed another deal with South Korea’s Samsung Biologics to get the drug manufactured on approval.
In 2016, Sun Pharma entered into a licensing agreement with Spain’s dermatology drug maker Almirall for the development and commercialisation of tildrakizumab in Europe. Almirall had agreed to lead European studies and participate in larger global clinical studies, subject to the terms of Sun Pharma.
Competitive landscape
The market size for plaque psoriasis in the US is around USD 7 billion, of which the market for Ilumya (Interleukin-based) is between USD 2.5 billion and USD 3 billion, and expanding fast. Sun will be the sixth player in a segment that is getting crowded. AbbVie and Boehringer Ingelheim are developing risankizumab, which is said to be among the best in terms of clinical results so far. Analysts expect Ilumya may be able to reach a peak sale of $350 million in three to four years.
Last year J&J launched Tremfya (directly competing with Sun’s Ilumya), which has a better safety profile compared to other existing brands.
The rest of the market is currently served by drugs like Humira and Enbrel, but their share is on a decline. The other big names include J&J’s Stelara; Novartis’s Cosentyx, Eli Lilly’s Taltz, and Valeant’s Siliq.
Sun’s strategy
Sun has been ramping up its commercial team in the US in anticipation of the Ilumya approval. Pricing will be a key determinant along with the convenience of lower dosing of the subcutaneous injection. J&J’s Stelara comes with a tag of USD 42,000 for a one-year course, but it will see a gradual decline with competition. To get listed on the formulary or with the health insurance, low pricing and convenience of administration are seen as important factors.